MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L

Model Number	EG-2990I
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary it was caused due to an excessive force on the ift and a fluid damage in the scope.In addition, we confirmed that the operation channel damage, the root brace rubber flexible tube torn, the ccd module failure, the lcb damage, the control body assy complete damage, and the u/d and r/l puller wires stretch; however, these are not related to the alleged complaint.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.There is a bump at distal side of the ift at 9 cm.

• Brand Name: PENTAX
• Common Device Name: HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12243733
• Report Number: 9610877-2021-10514
• Device Sequence Number: 4600337
• Product Code: FDS
• UDI-Device Identifier: 04961333248179
• UDI-Public: 04961333248179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EG-2990I
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1